Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession

NCT06621433 | Completed

• 1 other identifier: 1/1-2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (5)

• Probing depth

  The distance from the base of the pocket to the most apical point on the gingival margin will be measured using a periodontal probe.

  up to 6 months

• Clinical attachment loss

  Distance from the cement-enamel junction to the base of the periodontal pocket will be measured using a periodontal probe

  up to 6 months

• Recession width (RW)

  Recession width (W) measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth) using a periodontal probe

  up to 6 months

• Recession height (RH)

  It will be measured from the cementoenamel junction to the Gingival Margin (GM), parallel to the long axis of the tooth starting from the most apical point of the recession using a William's graduated periodontal probe

  up to 6 months

• Width of keratinized gingiva (KT)

  Width of keratinized gingiva will be measured as the distance from the gingival margin to the mucogingival junction

  up to 6 months

Study Arms (2)

Coronally advanced flap (CAF) in conjunction with titanium prepared PRF

EXPERIMENTAL

Other: T-PRF with CAF

CAF in conjunction with subepithelial connective tissue graft (SECTG)

ACTIVE COMPARATOR

Other: SECTG with CAF

Interventions

T-PRF with CAF OTHER

Blood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap.

Coronally advanced flap (CAF) in conjunction with titanium prepared PRF

SECTG with CAF OTHER

Sub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap.

CAF in conjunction with subepithelial connective tissue graft (SECTG)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gingival recession type 2 according to Cairo et al (2011).
• Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
• Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
• Clinically thick gingival biotype (1mm \< gingival thickness).
• Anterior esthetic zone.

You may not qualify if:

• Patients with gingival recession types 1 and 3 according to Cairo et al.
• Inadequate amount of attached gingiva (AG \< 2 mm).
• Uncooperative patients.
• Smoking more than 10 cigarettes per day.
• Patients with known systemic conditions or taking medications that may affect soft tissue healing.
• Pregnant and lactating women.
• Patients with parafunctional habits.

Sponsors & Collaborators

• Rizk Beshir: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc. candidate of periodontology

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: January 1, 2023
• Primary Completion: January 20, 2024
• Study Completion: January 22, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

EG (1)